You don't understand how impressive it is to get a p value of 0.001 with only 42 patients. The low numbers is not a criticism of that study. Rather its a marker of just how clear and easily shown the differences between MAT9001 and Vascepa are.

Yes...very long time to market for MAT9001 but the "whipping boy" garbage is absurd/reversed.

It was a Phase I study but maybe they will re-label it as a Phase I/II because they are going directly to Phase III after those results.

I mean who ever heard of a Phase I with
1. an active comparator
2. meeting all primary and secondary endpoints
3. being stopped early prior to full enrollment because of interim analysis showing #2
4. a p value of 0.001
5. the active comparator's company running huge trials that will mainly serve to support the superior agent

The probability of flipping heads 26 or more times out of 42 is ~8%. To match the p value seen in this study your example should be 31 heads out of 42. In other words if you flip a coin 42,000 times and look a every 42 in a row...you'd expect to see 31 heads or more....ONCE.

Google "coin flip p-value calculator" and choose first result "binomial calculator" to see for yourself.

Akanz2,
If our goal is to define if there is a difference in ability to reduce triglycerides AND if you accept the trial design then there is less than a 0.1% chance that another trial with more patients (or the same number of patients) will alter that finding. MAT9001 achieved that goal vs. active comparator which is a greater challenge than Vascepa had vs. placebo.

If the trial were to assess for cardiovascular risk (like Reduce IT) then it is a far more difficult/variable endpoint and I would expect something on the order of 4200 would be needed.

Your study design criticisms are interesting but the overall finding would be expected to stand unless you believe there was something about the design that could have favored one agent over the other...I do not believe that is the case.

P value less than 0.001 translates to "there is a less than 0.1% chance that the noted differences in effect occurred by chance"

The fact that it took so few patients to get to that level of statistical significance is remarkable and the low numbers of patients speaks to the profundity of differences in the effects. Powering of a study refers the number of subjects needed in order to show a statistically significant effect (usually meaning a p value less then 0.05).

42 patients. Crossover Phase I study with 2 weeks on MAT9001 or Vascepa, 5 weeks washout, then 2 weeks on the other compound. The study was planned for 50 patients but was stopped early because it had met all primary and secondary endpoints. P value for triglyceride reduction compared to Vascepa was less than 0.001.

Matinas (MTNB, company that makes MAT9001) gave a presentation last night and the replay should be be available on their website.

8k is basically the press release...it would be nice to know the amounts but we can glean:
1. They bought some already
2. They were impressed and agreed to buy more
3. They set up a new demonstration with a different area in the same navy facility

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